FDA Orange Book

Generic for Edluar

Edluar contains zolpidem. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.

Source: FDA Orange Book data file dated 2026-10-09. Publisher page

Yes. The generic name for Edluar is zolpidem. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Edluar products in the Orange Book

Edluar products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
tablet, sublingual	10MG	Marketed (Rx)	AB	1	AB
tablet, sublingual	5MG	Marketed (Rx)	AB	1	AB

NDA 021997, held by VIATRIS SPECIALTY LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic zolpidem

Approved generic versions of Edluar
Company	ANDA	TE code	Approved	Strengths
PH HEALTH LTD	201509	AB (A-rated, therapeutically equivalent)	August 1, 2016	10MG, 5MG

Edluar patents

Patents listed for Edluar
Patent	Expires	Covers	Use code	NDA
9597281	April 6, 2027	Method of use	U-674	021997
9265720	February 25, 2031	Method of use	U-674	021997

Edluar NDC codes

Questions

Is there a generic for Edluar?

Yes. The generic name for Edluar is zolpidem. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

What is the generic name for Edluar?

The active ingredient in Edluar is zolpidem, per the FDA Orange Book.

When does the Edluar patent expire?

The last patent listed for Edluar in the Orange Book expires February 25, 2031. A listed patent expiry date is not a generic launch date.

What does a therapeutic equivalence code mean?

In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.